Method and device for monitoring loss of body fluid and dislodgment of medical instrument from body

ABSTRACT

A method of alerting medical personnel of a problem during hemodialysis includes providing an active, fail-to-safe site sensor for a fistula needle at an access site during hemodialysis; and automatically alerting medical personnel of a problem during hemodialysis using the active, fail-to-safe site sensor during at least the following: failing of the active, fail-to-safe site sensor; insufficient powering to the active, fail-to-safe site sensor; partial fistula needle dislodging from the access site; and complete needle dislodging from the access site.

FIELD OF THE INVENTION

The present invention is in the field of methods and devices foralerting medical personnel of the leakage of blood or other fluids froma medical instrument insertion site into the body and of the dislodgmentof the medical instrument from the insertion site.

BACKGROUND OF THE INVENTION

A “fistula needle” is a large bore needle, commonly 14 to 17 gauge,which is bonded to a section of medical grade tubing used to connect thefistula needle to an extracorporeal blood circuit for use inhemodialysis.

Hemodialysis is one of the primary treatments for patients with kidneyfailure. These life-sustaining treatments typically require 3 to 4.5hours each and may occur three or more times a week. However, due todifferences in protocols, techniques, or varying patient needs, somehemodialysis treatment may last six hours or even overnight.

The most common access to the vascular system during hemodialysis, forchronic patients, is through use of a large gauge needle insertedthrough the skin into an arterial/ventricular graft, an implanted shuntor an implanted receptacle.

During a treatment, the patients' blood is processed by a filteringdevice commonly called a dialyzer or hemodialyzer. The blood travels toand from this filtering device through an extracorporeal blood circuitby the action of a blood pump. Every hemodialysis unit is required tohave certain alarms (AAMI RD5-3.3.6) that monitor conditions throughouta treatment to insure patient safety. These alarms include temperature,dialysate pressure, transmembrane pressure, blood circuit pressure,conductivity, blood leak, and blood circuit air embolism protection.

Blood travels out from the body through the arterial fistula needle toan arterial bloodline. The arterial blood is then pumped through thebloodline, into and through the filtering device, and returned to thebody through the venous bloodline attached to the venous fistula needle.As used herein, the term “venous” it is intended to mean “returning tothe body” and the term “arterial” is intended to mean “coming from thebody”. These fistula needles are commonly taped in place on thepatient's skin near and around the access site.

One or both of the fistula needles are occasionally dislodged or removedfrom the access site during a treatment. Some examples of how thishazardous situation may occur unintentionally include the bloodlinesgetting caught on the treatment chair during a positional change such asreclining from a seated position or siting up from a reclined position.Dislodgment may also occur when clothing or blankets brush against thefistula needles and tapings during normal movements. Sometimes someonemoving past catches the bloodline with a foot, a walker, a wheelchair ora cart. It may even happen when the tape on a patient simply comes off,due to dry or sweaty skin, and the needles slip out. Intentional removalof the needle(s) during treatment is also not unheard of, requiring manyof the more mentally or emotionally unstable patients to be restrainedduring treatments. Other patients move around frequently and the manylittle tugs on the bloodline and tapings, and the constant pullingeventually loosens that tapings to the point that they come off and thefistula needle falls out.

Should the venous needle become partially dislodged during a treatment,the patients' blood may infiltrate (into the surrounding tissue areas),usually causing great pain, or it may leak out around the needle entrysite, or a combination of both.

Should the venous needle become completely dislodged during ahemodialysis treatment, the patients' blood is not being returned andthe blood is effectively drained out. With typical blood pump ranges of50 to 650 ml/min., the blood loss may be very rapid. This situationrequires an immediate medical intervention response to prevent severepatient injury or death by exsanguination. Obviously, even the mostobservant and dedicated of medical staff could not possibly watch eachpatient all of the time.

Currently, the primary device to monitor for a venous needle dislodgmentis the venous pressure monitor (VPM). Under certain circumstances, VPMis not a dependable indicator for a venous needle dislodgment becausethe VPM may not “see” a change beyond the standard alarm limit range (50ml/min.). This may be exacerbated when the alarm limits are not set“centered” around the varying average pressure. Significantly, the VPMwill often fail to register a sufficient pressure change (to set off analarm) due to the inherent “back pressure” developed in a venous bloodline by the resistance of the viscous blood traveling through therelatively small orifice of the fistula needle.

One attempt to solve the partial dislodgment problem is offered by Shawin his U.S. Pat. Nos. 3,618,602 and 4,010,749. These basically use theincrease in skin temperature to determine the presence of aninfiltration. This solution has limitations in that it is rather slow torespond as it is dependent on the reaction of the body to the problem.Additionally, it fails to address the present concern of dislodgment.While an infiltration is painful, may require surgery to correct andcould even result in the loss of the limb, it is not immediately lifethreatening.

One proposed solution to the complete dislodgment problem is attemptedin U.S. Pat. No. 6,077,443, entitled “Method and device for monitoring avascular access during a dialysis treatment”, issued to Goldau, Rainer,which monitors the impulses (natural or added) detectable in anextracorprial blood circuit. This method has not experienced commercialsuccess, or widespread utilization. It is believed this may be becausethe pressures illustrated appear to be on a very still patient, which isnot a realistic assumption throughout a four-hour or longer treatment.Even very small arm movements can set off the VPM without dislodgment ofa needle because of the natural pressures inherent in the needle asdescribed above.

There are a number of sensor designs that use the inherent conductivityof blood and other fluids to set off an alarm, most commonly used in adiaper to indicate a soiled condition.

A “System for use in detection of electrically conductive fluids” wassuggested in U.S. Pat. No. 5,790,036, issued to Fisher, et al., whichuses the inherent conductivity of body fluids and wastes to set off analert in a diaper. This arrangement does not adequately protect apatient as it could have a sensor failure or disconnect without alertingthe staff of the sensor failure or disconnection. Additionally, thedevice does not explicitly provide for compliance with the nonisolatedpatient connection requirements of Safe Current Limits for EletromedicalApparatus as required by Applicable Document 2.3.

U.S. Pat. No. 5,779,657 to Daneshvar entitled “Nonstretchable woundcover and protector” shows and describes a simple blood leak detector.The soiling of a gauze pad with blood would complete a circuit, allowingan alarm to sound. As in the case of the Fisher unit, Daneshvar's unitfails to alarm in the case of a sensor failure. Daneshvar's unit also isnot compliant with the nonisolated patient connection requirements forelectrically sensitive patients. Additionally, whether Daneshvar's unitwill alarm depends on the absorbency of the gauze, which may becompromised due to being saturated by non-conductive fluids or bycompression, or coated by certain medical gels, pastes or ointments.

The devices described in WO 99/24145 and U.S. Published PatentApplication 2002/0198483 A1 attempt to detect a separation of theextracorporeal circuit. However, neither of these allow for anunobstructed view of the access site. Another problem they share is thatthey are designed for use as an integral part of a dialysis machine. Assuch, they are specifically not designed for stand-alone use. Of greaterconcern is the failure of any of these devices to fail in a safe manner.If the unit fails for some reason, such as a dead battery, theprotection is lost and the staff is not aware of it. While both of thesereferences indicate that they determine needle dislodgment, they reallyare mere variations on the wet diaper sensor idea in that they onlydetect blood or other conductive fluids. They are not actuallydetermining the needle position. With some of the newer implanted tubingand other new types of vascular accesses, there is very little bleedingwhen a needle is removed, and, hence, limited opportunity for success inalerting the staff in the case of a rapid needle withdrawal, such aswhen a bloodline is caught by a passing foot, or when a mentallyunstable patient intentionally removes the needle. Additionally, inapplications other than dialysis, the underlying region or substratesmay not have a sufficient positive relative pressure to force out blood,body fluid or liquid to wet the sensor.

The reusable sensors described in the references mentioned above andelsewhere in the prior art involve the myriad of problems and costsassociated with reusing soiled medical equipment including, but not byway of limitation, sterilization, clean storage, verification of theabsence of the sterilant prior to use, reused devices being reused onlyby the original patient, quality problems due to subjective assessments,etc.

SUMMARY OF THE INVENTION

The present invention involves a device for monitoring loss of bodyfluid and dislodgment of a medical instrument from an access site of thebody. The device involves a system that is designed for use as acritical medical monitor, provides the requisite electrical isolation,and provides an unobstructed view of the access site. The deviceincorporates a sterile and disposable sensor that fails-to-safe suchthat a loss of protection results in an alarm, can be reset in the caseof small leaks, can be tested “in-situ”, without extra test equipment,alarms if the patch is removed or damaged in use, can stand alone and isnot be required to be integrated into the alarm circuits of common,existing hemodialysis units, monitors the placement of the needlerelative to its insertion point, has a monitored power supply, andalarms in the intentional removal of needle by patient.

Another aspect of the invention involves a hemodialysis site sensorattachable to at least one of a blood line and a fistula needle foralerting medical personnel of the leakage of blood from an access sitewhere the fistula needle enters into a patient's body and dislodgment ofthe fistula needle from the access site. The hemodialysis site sensorincludes a base membrane layer made of a medical-grade, biocompatiblematerial and including an upper side, a lower side adherable to skin ofthe patient, and one or more holes disposed therein to allow the passageof blood and vapor therethrough; a first membrane layer including anupper side, a lower side, and one or more holes disposed therein toallow the passage of blood and vapor therethrough; a third membranelayer including an upper side and a lower side; an electrical connectionadapted to be electrically coupled to an analytical circuit andincluding a first sensing array disposed between the upper side of thebase membrane layer and the lower side of the first membrane layer, asecond sensing array disposed between the upper side of the firstmembrane layer and the lower side of the third membrane layer, andresistively connected to the first sensing array; a disconnectionmechanism attachable to at least one of the blood line and the fistulaneedle and severing the electrical connection upon dislodgment of thefistula needle from the access site; and wherein an electrical signalsent through the electrical connection changes when blood contacts atleast one of the sensing arrays or the electrical connection is severedby the disconnection mechanism, causing the analytical circuit toactuate an alarm notifying medical personnel of partial or totaldislodgment of the fistula needle from the access site.

Another aspect of the invention involves a method of alerting medicalpersonnel of partial and total dislodgment of a fistula needle from anaccess site where the fistula needle enters into a patient's body duringhemodialysis. The method includes providing a site sensor including abase membrane layer made of a medical-grade, biocompatible material andincluding a lower side adherable to skin of the patient at the accesssite, and one or more holes disposed therein to allow the passage ofblood and vapor therethrough, a top membrane layer, an electricalconnection including one or more resistively connected sensing arraysdisposed between the base membrane layer and the top membrane layer, anda disconnection mechanism attachable to at least one of the blood lineand the fistula needle and severing the electrical connection upondislodgment of the fistula needle from the access site; providing ananalytical circuit in electrical communication with the electricalconnection; sending a signal from the analytical circuit to the sitesensor and receiving the signal from the site sensor with the analyticalcircuit, the signal traveling through the one or more resistivelyconnected sensing arrays of the electrical connection; partiallydislodging the fistula needle from the access site causing blood tocontact the one or more resistively connected sensing arrays and thesignal sent from the analytical circuit to change; completely dislodgingthe fistula needle from the access site causing the disconnectionmechanism to sever the electrical connection and the signal sent fromthe analytical circuit to change; determining with the analyticalcircuit whether the signal changed outside of a predetermined range; andactuating an alarm with the analytical circuit if the signal changedoutside of a predetermined range.

A still further aspect of the invention involves a method of alertingmedical personnel of a problem during hemodialysis. The method includesproviding an active, fail-to-safe site sensor for a fistula needle at anaccess site during hemodialysis, for a needle, or for another skinpenetrating medical device; and automatically alerting medical personnelof a problem during hemodialysis using the active, fail-to-safe sitesensor during at least the following: failing of the active,fail-to-safe site sensor; insufficient powering to the active,fail-to-safe site sensor; partial fistula needle dislodging from theaccess site; and complete needle dislodging from the access site.

Further objects and advantages will be apparent to those skilled in theart after a review of the drawings and the detailed description of thepreferred embodiments set forth below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front elevational view of a human and illustrates multipleexemplary vascular and peritoneal access sites.

FIG. 2A is front perspective view of an embodiment of a dialysistreatment chair in a normal position.

FIG. 2B is right perspective view of the dialysis treatment chair ofFIG. 2A and illustrates the chair in a reclined position.

FIG. 2C is right side elevational view of the dialysis treatment chairof FIG. 2A and illustrates the chair in a fully reclined, Trendlenburgposition.

FIG. 3 is a front perspective view of an embodiment of a hemodialysisunit connected to a dialysis patient sitting in a dialysis treatmentchair.

FIG. 4 is an exploded perspective view of an embodiment of a site sensorof the system for monitoring loss of body fluid and dislodgment of amedical instrument from an access site of the body.

FIG. 5A is a cross-sectional view of the site sensor taken along lines5A-5A of FIG. 4.

FIG. 5B is a cross-sectional view of the site sensor taken along lines5B-5B of FIG. 4.

FIG. 6 is a perspective view of the site sensor of FIG. 4 applied to apatient's arm with a bloodline of an extracorprial blood circuit andconductive wires shown extending from the site sensor.

FIG. 7 is an electrical schematic of an embodiment of an analyticalcircuit and enunciator that may be used with the site sensor.

FIG. 8 is a perspective view of an alternative embodiment of a sitesensor applied to a patient's arm with a fistula needle/bloodline of anextracorprial blood circuit and conductive wires shown extending fromthe site sensor.

FIG. 9 is a top plan view of another embodiment of a site sensor.

FIG. 10 is a top plan view of a further embodiment of a site sensor.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

With reference to FIGS. 1-10, an embodiment of a system and method formonitoring a vascular access site of a patient 105 during a hemodialysistreatment and alerting the medical staff in the event of a needledislodgment will be described.

Although the system will be described in conjunction with monitoring avascular access site during a hemodialysis treatment, the system may beused for monitoring any penetration or access site through the skin withrespect to blood, body fluids, and/or medical fluids that may leakaround the skin penetration site and/or dislodgment of a needle relativeto the skin penetration or access site. Further, the system may be usedfor monitoring access of the vascular system, access to sub-dermal orother implanted devices, access of the peritoneal cavity, access ofinternal organs, monitoring trans-dermal exudation, other usage where analert to the leakage of blood, body fluids, medical fluids, liquids orother fluids may be desired, or other usage where an alert to theseparation of a medical device or instrument from an access site of thehuman body may be desirable.

Before describing the system in detail, hemodialysis and some of theequipment used during hemodialysis will first be described.

Hemodialysis is one of the primary treatments for patients 105 withkidney failure. These life-sustaining treatments typically require 3 to4.5 hours each and may occur three times a week. The most common accessto the vascular system, for chronic patients, is through use of a largegauge needle inserted through the skin into an arterial/ventriculargraft, an implanted shunt or an implanted receptacle at one of thecommon sites 110 (FIG. 1) used for access to the vascular system of thepatient 105. While the illustrated sites in FIG. 1 are not exhaustive,these sites are the normal locations for accessing the blood supply foruse in hemodialysis and apheresis as well as where the interventionalradiologist accesses the primary blood vessels for access to the heart.Several of these locations are viable for infusion therapy as well.

The use of medical tape and a patch of sterile gauze covering theperitoneal insertion site 120 should be noted because this is an exampleof a site that may be monitored by the system in an alternativeembodiment for any leakage, bleeding, or oozing which would indicateinfection.

During a treatment, the blood of the patient 105 is processed by ahemodialysis unit 130 (FIG. 3). The blood travels to and from thehemodialysis unit 130 through bloodlines 140 of an extracorporeal bloodcircuit by the action of a blood pump in the hemodialysis unit 130.

Blood travels out from the body through an arterial fistula needle 150(FIG. 6) to an arterial bloodline 160, which may be connected to thearterial fistula needle 150 by a leader and appropriate luer lockfittings. The arterial blood is then pumped through the arterialbloodline 160, into and through the hemodialysis unit 130, and returnedto the patient 105 through a venous bloodline attached to a venousfistula needle.

During the dialysis process, the patient 105 normally rests in a typicaldialysis treatment chair 170 (FIGS. 2A-3) in one of three positions: 1)a normal sitting position (FIG. 2A), 2) a reclined sitting position(FIG. 2B), and 3) a fully reclined or Trendelenburg sitting position(FIG. 2C). The fully reclined position or Trendelenburg sitting positionshown in FIG. 2C is used to lower the head of the patient 105 below thelevel of the heart and is used when the blood pressure of the patient105 gets too low (“crashing”) and staff is attempting to prevent thepatient 105 from blacking out. It is important to note the many cornersof the chair 170 and other features of the chair 170 that provideopportunities for the needle 150 to be pulled on when changing from onesitting position to another. Bloodlines 140 may get caught on thetreatment chair 170 during a positional change such as reclining from aseated position or sitting up from a reclined position, causing one orboth of the fistula needles to become partially or completely dislodgedor removed from the access site during dialysis. Dislodgment may alsooccur when clothing or blankets brush against the fistula needles andtapings during normal movements by the patient 105.

It is also important to notice that, as with most chairs, the sides ofthe chair 170 are covered, which often greatly increases the timebetween when the needle 150 is dislodged and when it is noticed by themedical staff by observation of a growing puddle of blood on the floorunder the expiring patient 105. The presence of sides on dialysis chairs170 also causes the problem of clothing or blankets tending to bunch upin the lower corners of the chair 170, soaking up blood that isleaking—again extending the time between when the needle 150 isdislodged and when it is noticed by the medical staff.

The drawing of FIG. 3 illustrates how the bloodlines 140 dangle betweenthe chair 170 and the hemodialysis unit 130 during the typical dialysisprocess, and the danger this represents due to the fistula needles andbloodlines 140 being accidentally caught and pulled from the patient 105during dialysis due to the length of the bloodlines and their potentialfor interference with the medical attendants that serve the patient 105undergoing dialysis. In certain situations, such as when a dialysistreatment station is positioned in a corner, the hemodialysis unit 130may be on the side of the patient 105 opposite the patient's access tothe chair 170. In this case, the bloodlines 140 actually cross over thepatient 105, significantly increasing the risk of having the bloodlines140 being inadvertently caught on something or pulled on. Sometimessomeone moving past catches the bloodlines 140 with a foot, a walker, awheelchair or a cart.

Should the venous needle become partially dislodged during dialysis, theblood of the patient 105 may infiltrate (into the surrounding tissueareas), usually causing great pain, or it may leak out around the needleentry site, or a combination of both.

Should the venous needle become completely dislodged during ahemodialysis treatment, the blood of the patient 105 is not beingreturned and the blood is effectively drained out. With typical bloodpump ranges of 50 to 650 ml/min., the blood loss may be very rapid. Thissituation requires an immediate medical intervention response to preventsevere patient injury or death by exsanguination.

With reference to FIGS. 4-7, the system will first be generallydescribed followed by a detailed description of the elements of thesystem. The system generally includes a site sensor 180 (FIGS. 4-6), ananalytical circuit 190 (FIG. 7), and an enunciator 200 (FIG. 7). Aelectrical signal is sent from the analytical circuit 190 to the activesite sensor 180, where the signal passes through one or more sensingarrays of the site sensor 180, and back out to the analytical circuit190. The analytical circuit 190 monitors the return signal. Any changeof this returned signal outside of a designated range produces an alarmoutput, which is coupled to the enunciator 200, for alerting medicalpersonnel. The site sensor 180 includes a disconnection mechanism thatdisconnects the site sensor 180 from the analytical circuit 190 uponsufficient pull of the bloodline 160. This changes the returned signalto the analytical circuit 190, producing an alarm output that is sent tothe enunciator 200 for alerting medical personnel.

Each of main elements of the system will now be described in more detailin turn below:

Site Sensor:

With reference to FIGS. 4-6, the embodiment of the site sensor 180 shownincludes a base membrane layer 210, a second membrane layer 220, and athird membrane layer 230. A first conductive layer or sensing array 240is disposed between the base membrane layer 210 and the second membranelayer 220, and a second conductive layer or sensing array 250 isdisposed between the second membrane layer 220 and the third membranelayer 230. Although the sensing arrays 240, 250 are shown separated bythe single second membrane layer 220, in an alternative embodiment, thesensing arrays 240, 250 may be separated by more than one layer and/ormay have additional sensing layers between them.

The base membrane layer 210 is made up of one or more appropriatemedical-grade, biocompatible materials, and have a rectangular shape asshown or may have a different shape. The same may be true for the othermembrane layers 220, 230. An underside of the base membrane layer 210may be completely or partially coated or circumscribed with a coating ofmedical-grade, biocompatible adhesive 252 (FIGS. 5A, 5B) covered by aremovable sheet to allow for the attachment of the site sensor 180 tothe prescribed area on the patient 105. The adhesive may include one ormore adhesives of different adhesive strengths to facilitate controlledseparation of the site sensor 180 along prescribed lines 270 or at theconnector of the site sensor 180 in a manner to be described device whena dislodging stress is applied to the bloodline 160 to interrupt thesignal being transmitted through the site sensor 180 and cause an alarmcondition. The site sensor 180 may also be held in place by any numberof methods, as known to those skilled in the art, in conjunction with orin place of the medical-grade, biocompatible adhesive. The locationalstability of the site sensor 180 is of paramount importance to thefunctional benefit of the system. The site sensor 180 in every case mustbe firmly attached to the fistula needle 150 and/or the bloodline 160.This attachment may be made during manufacturing, attached at time ofuse, or sometime in between.

In an alternative embodiment, the base membrane layer 210 may carry oneor more electrodes somewhat below the base membrane layer 210 toindicate positive contact with the skin of the patient 105. An exemplaryelectrode that may be used for this purpose is a silver/silver-chloridetype as is used in a plethysmograph or an ElectroCardioGram (ECG) leadset; however, other types of electrodes, as is known to those skilled inthe art, and/or additional sensors may be used. The one or moreelectrodes and/or sensors may be coupled to the first sensing array 240or have another electrical connection for the purpose of determiningactual physical contact with the skin of the patient 105. The firstsensing array 240 may, if placed below the base membrane layer 210 or inthe absence of the base membrane layer 210, provide a biorhythm output(e.g., an ECG waveform may be transmitted to the analytical circuit 190)that is indicative of a good and stable connection with the patient 105.An additional advantage of this is that if the patient expires, thusending the waveform, an alarm at the enunciator 200 may be actuated.

The base membrane layer 210 may have holes 260 to allow for the freepassage of perspiration, blood, other liquids and/or vapors through thelayer. One of more of these holes 260 may be of the same or varyingsizes, shapes, quantities and regional densities. The base membranelayer 210 (and the other membrane layers 220, 230) may have aperforation 270, or other preconditioning treatment, along a prescribedpath to facilitate the destruction of the site sensor 180 alongprescribed lines in the case of a physical force against it from a pullon the bloodline 160 or fistula needle, again resulting in an alarmstate. The perforation 270 may terminate in a generally rectangularcut-out 266, which delineates a pull-over adhesive tab 268 of adetachment section 269. The adhesive tab 268 may include an adhesivecovered by removable sheet on its upper surface. The pull-over adhesivetab 268 and the perforation 270 combine to form a dislodgment mechanism.In alternative embodiments, the dislodgment mechanism may havealternative configurations, different elements, and/or greater or fewerelements. With reference to FIG. 6, in use, bloodline 140 and/or fistulaneedle 150 is placed through the cut-out 266, over the adhesive tab 268and under the rest of the site sensor 180, the removable sheet isremoved from the adhesive tab 268, exposing the adhesive, and theadhesive tab 268 is folded over the bloodline 140 and/or fistula needle150 and adhered to the upper surface of the third membrane layer 230 sothat the bloodline 140 and/or fistula needle 150 is firmly attached tothe tab 268 such that a pull on the bloodline 140 would separate theconductive wires 272 or connection 284 and detachment section 269 fromthe rest of the site sensor 180 along the perforation 270, thusinterrupting the conductive path and causing the analytical circuit 190to cause the actuation of an alarm at the enunciator 200.

An upper side of the base membrane layer 210 may be used as a base forthe first sensing array 240 to be placed, painted, deposited, adheredto, or otherwise disposed on. The first sensing array 240 may be heldbetween the base membrane layer 210 and the second membrane layer 220,and include a plurality of conductive wires or traces 272. One ofconductive wires 273 (FIG. 6) connecting the site sensor 180 and theanalytical circuit 190 may be connected to the first sensing array 240at a connection point 274 (FIG. 4) at one end of the first sensing array240. One or more resistors 276 may be located at an opposite end of thefirst sensing array 240 and may be used to resistively connect the firstsensing array 240 to the second sensing array 250 through a hole 278 inthe second membrane layer 220. The first sensing array 240 may have aconfiguration and be positioned so as to evenly cover the area betweenthe base membrane layer 210 and the second membrane layer 220. The firstsensing array 240 may cover some, all, or none of the holes 260 in thebase membrane layer 210. The first sensing array 240 may be embedded inone of the layers 210, 220, or may be simply attached to or held inplace between the layers 210, 220. The first sensing array 240 may be ofone polarity or made up of multiple leads with several polarities.

The second membrane layer 220 may also have holes 280, one or more ofwhich may be of the same or varying sizes, shapes, quantities andregional densities.

These holes 280 may or may not line up with the holes of any otherlayer. The top of the second membrane layer 240 may be used as a basefor the second sensing array 250 to be placed, painted, deposited,adhered to, or otherwise disposed on. The second sensing array 250 maybe held between the second membrane layer 220 and the third membranelayer 230, and include a plurality of conductive wires or traces 282.One of the conductive wires 273 connecting the site sensor 180 and theanalytical circuit 190 may be connected to the second sensing array 250at a connection point 284 at one end of the second sensing array 250 bysoldering or any other well-known electric connection manner. Theseconnectors may be of a calibrated strength or holding ability. Thesecond sensing array 250 is connected to the one or more resistors 276at an opposite end of the second sensing array 250. The second sensingarray 250 may have a configuration and be positioned so as to evenlycover the area between the base membrane layer 210 and the secondmembrane layer 220. The second sensing array 250 may cover some, all, ornone of the holes 280 in the second membrane layer 220. The secondsensing array 250 may be embedded in one of the layers 220, 230, or maybe simply attached to or held in place between the layers 220, 230. Thesecond sensing array 250 may be of one polarity or made up of multipleleads with several polarities.

The sensing arrays 240, 250 are preferably resistively connected throughthe one or more resistors 276, allowing for the fail-to-safe feature ofthe present invention, which will be described in more detail below. Inalternative embodiments, the wires or traces of both arrays 240, 250 maybe made of a resistive material.

Although the sensing arrays 240, 250 have been described as having aconfiguration and being positioned so as to evenly cover the areabetween the layers 210, 220, 230, the coverage of the areas by thesensing arrays 240, 250 may not necessarily be even. In alternativeembodiments, differing amounts of coverage in differing areas may occur.For example, a space may be located near the center of the site sensor180 to allow penetration through the site sensor 180 without damaging,disturbing, or contacting any of the sensing arrays 240, 250.

The third membrane layer 230 is also made of one or more appropriatemedical-grade, biocompatible materials. The third membrane layer 230preferably does not include holes like the base membrane layer 210 andthe second membrane layer 220, but is preferably made of one or moreappropriate materials to allow for the transpiration of perspiration andvapor, but not blood or other liquids. This selectively orsemi-permeable layer 230, together with the seal formed by the adhesiveof the base membrane layer 210, ensures that the sensing arrays 240, 250will come into contact with any blood or liquids that may be coming fromthe protected area.

Outer edges of the membrane layers 210, 220, 230 may be sealed, glued orbonded to one-another in any manner as known to those skilled in theart.

The site sensor 180 is preferably transparent in all of the one or morelayers above the needle entry site.

With reference to FIG. 8, an alternative embodiment of the site sensor180 is shown where conductive leads 273 connect with the site sensor 180at detachment corner sections 292 near an end of the site sensor 180opposite the detachment section 269 and wrap around the limb of thepatient. A cinching mechanism 300 may be used to cinch the conductiveleads 273 snugly against the limb to help to make the physical locationand security of the site sensor 180 against the limb more stable. Thebloodline 160 is secured to the site sensor 180 by the adhesive tab 268of the detachment section 269 in a manner similar to that describedabove with respect to FIGS. 4-6 so that the force that would dislodgethe fistula needle 150 causes the adhesive tab 268 and detachmentsection 269 to tear away from the site sensor 180 along the perforation270 and interrupt the conductive path which would be detected by theanalytical circuit 190, producing an alarm. Similarly, the force thatwould dislodge the fistula needle 150 (or movement of the patient's arm)may cause the site sensor 180 and one or both of the detachment cornersections 292, which are adhered strongly to the patient's skin, toseparate along one or both perforations 294. This would interrupt theconductive path which would be detected by the analytical circuit 190,producing an alarm. In alternative embodiments, one or both of theperforations 276, 294 of the site sensor 180 may have a straight,rectilinear, or curvilinear configuration other than that shown.

In an alternative embodiment where the site sensor 180 is not used, onecould simply wrap a wire similar to the conductive leads 290 around thelimb of the patient and secure the wire to the fistula needle 150 toprovide for an indication of needle dislodgment without leak detectionbecause pulling on the bloodline 160 causes the wire to sever andinterrupt the conductive path which would be detected by the analyticalcircuit 190, producing an alarm. In this embodiment, it would bedesirable to secure the wire onto the limb with medical tapes, patchesor manner known to those skilled in the art.

In the immediate following paragraphs, features that may be part of oneor more of the implementations of the system or site sensors 180, 310,350 (hereinafter “site sensor 180”) described herein are indicated.

For example, in one or more implementations of the system, the systemmay include one or more of the following. The entire system is containedin a single unit. One or more of the site sensor 180, the analyticalcircuit 190 and the enunciator 200 are integrated with each other. Thesystem is used for monitory blood/fluid leakage and/or needledislodgment of at an access site of a human or animal. The site sensor180, the analytical circuit 190 and the enunciator 200 are connected toeach other with any mechanical connection device. The site sensor 180,the analytical circuit 190 and the enunciator 200 are connected to eachother with any electrical connection device. The site sensor 180, theanalytical circuit 190 and the enunciator 200 are connected to eachother with any hollow fiber or solid fiber device. The site sensor 180,the analytical circuit 190 and the enunciator 200 are connected via anytelemetering type equipment. The site sensor 180, the analytical circuit190 and the enunciator 200 are connected via any optical/photonic typeequipment. The site sensor 180, the analytical circuit 190 and theenunciator 200 are connected via any combination of equipment type. Thesite sensor 180 and enunciator 200 are controlled by a separate,distinct controller. The site sensor 180 has a series of tabs at theedges that have the connective areas of the conductive traces or leads.The site sensor 180 has a series of tabs at the edges that have theconnective areas of the conductive traces or leads with fold-over tabsthat complete the circuit such that all tabs are folded over (with selfadhesive contacts) thus continuing the circuit, terminating at the onecorner or tab where the actual connector leading to the analyticalcircuit 190 or enunciator 200 (or a combination of the two) is located.The site sensor 180 has a series of conductive rings that surround theexterior of the site sensor 180 such that a connector could be attachedat any part of the edge of the site sensor 180 and make full contactwith the required leads of the sensing array. The site sensor 180utilizes a stereo or other style plug with as many discrete contactingareas as necessary. The site sensor 180 has a contact or connector ateach level which may or may not be interconnected to each other (allowsfor various levels to be active). The site sensor 180, sensor/analyticalcircuit, or sensor/analytical circuit/enunciator assembly isself-adhesively attached to, or in position on, the monitored site onthe subject. The site sensor 180, sensor/analytical circuit, orsensor/analytical circuit/enunciator assembly which is self-adhesivelyattached to, or in position on, the monitored site on the subject has anadhesive that is varied in its relative adhesive strength in order tofacilitate destruction of the site sensor 180 along prescribed paths.The site sensor 180, sensor/analytical circuit, or sensor/analyticalcircuit/enunciator assembly is attached to, or in position on, themonitored site on the subject with one or more of (a) an arrangement ofmaterial(s), fibers, plastics, tubing, straps, or other useful productor device, tied, connected, bonded or otherwise joined so as to hold thesite sensor 180, sensor/analytical circuit, or sensor/analyticalcircuit/enunciator assembly in contact with, or in position on, themonitored site of the subject; (b) an arrangement of adhesive tapeswhich may or may not be directly connected to the site sensor 180,sensor/analytical circuit, or sensor/analytical circuit/enunciatorassembly in contact with, or in position on, the monitored site of thesubject; (c) a clamp arrangement so as to physically hold the sitesensor 180, sensor/analytical circuit, or sensor/analyticalcircuit/enunciator assembly in contact with, or in position on, themonitored site of the subject; (d) any combination of the methods (a),(b), and/or (c) so as to hold the site sensor 180, sensor/analyticalcircuit, or sensor/analytical circuit/enunciator assembly in contactwith, or in position on, the monitored site of the subject. The powersupply and analytical circuit 190 are contained within a dialysis unit.The power supply and analytical circuit 190 are contained within anapheresis unit. The power supply and analytical circuit 190 arecontained within an infusion unit. The power supply and analyticalcircuit 190 are contained within a medical instrument or other medicaldevice. The power supply and analytical circuit 190 are contained withinan infusion pump unit. The site sensor 180 is connected to theanalytical circuit 190 and/or enunciator assembly with a conductivewire, set of wires, coiled wire set or any other form of conductivewiring or cable as know to those skilled in the art. The site sensor180, sensor/analytical circuit, or sensor/analytical circuit/enunciatorassembly is attached to seat, bed, mattress, float, cushion, gurney,wheelchair, or any other physical device for support of the patient. Thesite sensor 180, sensor/analytical circuit, or sensor/analyticalcircuit/enunciator assembly is attached to the floor, ceiling, wall,post, column, bar, or any other physical structure on, around or nearthe patient.

In one or more implementations of the site sensors 180, 310, 350, thesite sensors 180 may include one or more of the following. There may beother numbers of layers of material and varying areas covered by one ormore sensing arrays, which may have their own electrical connector, sothat differing volumes of liquid are required to generate an alarm.There may be concentric areas of sensing arrays to allow for multiplelevels of protection or to allow resetting of the system without havingto use a new site sensor 180. The site sensor 180 may include a testsection to allow for functional verification of the site sensor 180. Thesite sensor 180 may allow for oblique and/or perpendicular piercing ofthe site sensor 180 by one or more needles and may allow for theattachment of the one or more needles in the manner shown and describedabove. Such an embodiment would be ideal for use with the devicesimplanted in the upper chest or clavicle area such as the Vasca device,for such items as drainage tubing as used in many surgeries, and for usewith indwelling catheters and central line catheters and the like. Thespace or gap between the layers 210, 220, 230 may be varied or functionas the calibrated variable in determining how much blood or other fluidis required to set off the alarm in the site sensor 180. One or moredrain holes may be included in the site sensor 180 to allow blood orother occluding fluid that may have set off the alarm to be cleared.After the fistula needle 150 has been repositioned, a press on the topof the site sensor 180 would cause the displacement of the blood oroccluding fluid out of the one or more drain holes, which may have avalve or other flow control device, and allow the continued use of thesite sensor 180 without having to replace it. This would be ofsignificant advantage in the case of a larger sized site sensor 180 suchas a site sensor 180 for larger wound coverings or for monitoring shuntssuch as those used in radiographic heart studies (angiograms,angioplasty, etc.). Alternatively, the site sensor 180 may include a“luer lock” or other tubing or syringe connector to allow the use ofnonconductive sterile water or even air to rinse the site sensor 180 outin-situ. In such an embodiment, the third membrane layer 230 may haveone or more vent holes to facilitate this.

In one or more implementations of the site sensor 180, the site sensor180 may include one or more of the following. The site sensor 180 is aswitch. The site sensor 180 is disposable. The site sensor 180 isreusable. The site sensor 180 has a limited life cycle or number ofuses. The site sensor 180 is active. The site sensor 180 is passive. Thesite sensor 180 is electronic. The site sensor 180 is photonic. The sitesensor 180 is chemical. The site sensor 180 is mechanical. The sitesensor 180 is reactive to any contact, stress, temperature, light, odor,chemical, electrical potential, or any other measurable physicalproperty. The site sensor 180 is reactive to one or more of contact,stress, temperature, light, odor, mechanical, chemical, electrical orelectronic property, and any other measurable physical property. Thesite sensor 180 reacts in the absence of any one of contact, stress,temperature, light, odor, electrical or electronic property, mechanical,chemical, optical or any other physical property of the site sensor 180being monitored. The site sensor 180 is comprised of various layers ofhydrophobic and/or hydrophilic materials. The site sensor 180 iscomprised of various layers of transparent, medical-grade, biocompatiblematerials. One or more of the layers of the site sensor 180 haspenetrations, holes, openings, or a path or paths through it or themwhich would allow liquid underneath to freely flow through the variouslayer(s). The various penetrations, holes, openings, path or paths ofthe site sensor 180 are in any number, size, shape, origin,concentration, paucity, permeability, durability or function. Thevarious penetrations, holes, openings, path or paths of the site sensor180 are differing in number, size, shape, origin, concentration,paucity, permeability, durability or function. The various penetrations,holes, openings, path or paths of the one or more site sensors 180 arediffering in number, size, shape, origin, concentration, paucity,permeability, durability or function vary from layer to layer. Themembrane layer is reactive to the presence or absence of liquid or vaporand can alter, adjust, moderate, amplify, augment or otherwise vary thesize, shape or other feature of the holes, openings, path or paths orany other route through the membrane. The site sensor 180 is acombination of opaque materials. The site sensor 180 contains an areathat is perforated, thinned, weakened or otherwise made so as to directforce (a shearing force) along a predetermined path on, along, across,over or otherwise through the site sensor 180 so as to ensure that thepatch is separated from itself, or bisected, thus changing theelectrical, mechanical, chemical, optical, sonic or any other monitoredphysical property of the site sensor 180 due to a physical force beingapplied to it. The site sensor 180 contains the aforementionedperforated, thinned, weakened or force-directing section wherein thatsection may or may not cross the entirety of the site sensor 180. Theperforated, thinned, weakened or force-directing sections of the one ormore layers may be different at each layer. The site sensor 180 containsthe aforementioned perforated, thinned, weakened or force-directingsection wherein that section may not be in a straight line but rather inan angle, circle or other shape as it may be desired. The site sensor180 contains the aforementioned perforated, thinned, weakened orforce-directed section wherein that section is at a corner or at one ofthe corners or edges of the site sensor 180. The active sensing area ofthe layers is made of wire, traces, various conductive material, metals,painted traces, liquid conductive applications, sputtered deposition,vapor deposition build up, MEMs production, photolithography, or otherelectrical connection production method. The site sensor 180 has aconductive phase or array that may or may not dissolve in the presenceof a liquid or vapor. The site sensor 180 is in any shape, thickness, orcuvature as may be desirable for application to differing areas of thebody. The active sensing area of the differing levels is of differingsizes and/or shapes. The specified area of the site sensor 180,throughout its layers, has a region where there is no active sensingarea to allow for penetration through the site sensor 180 itself by aneedle or other device or observation or other monitor access. The sitesensor 180 has included in it any additional site sensor 180 that isable to determine the actual physical contact with the body beingmonitored. The site sensor 180 has included in it the ability to sensethe degree of actual physical contact with the body being monitoredusing a applied sensing method such as, but not limited to optical,thermal, and sonic. The site sensor 180 contains wet, dry or both wetand dry components. The site sensor 180 contains any of the known typesof “dry jell” products. The site sensor 180 contents and constructionmay be monolithic or of discrete components. The site sensor 180 iscomprised entirely of, or has as components, membranes or layers thatare permeable by vapors. The site sensor 180 includes vapor permeablemembrane layers where the membrane layers are of differing and/orvariable permeability. The site sensor 180 layers are sewn, bonded,connectored, sealed, fused, adhesively attached, glued, melted togetheror connected by any other method known to those skilled in the art. Theperimeter of the site sensor 180 is surrounded by an area of absorbentmaterial. The site sensor 180 includes layers of absorbent materials.The site sensor 180 monitors any physical property that can be measuredor gauged. The site sensor 180 is comprised of thermistors, thermaltransducers, or thermal detectors to provide output to the analyticalcircuit. The site sensor 180 uses exothermic or endothermic chemical(s)to enhance the responsiveness of the thermistors, thermal transducers,or thermal detectors. The site sensor 180 uses a hydrophilic product inconjunction with a reed switch or other mechanical switch that would becaused to change states due to pressure from the filling of thehydrophilic materials applying pressure against the switch. Thehydrophilic switch may or may not be encased inside of a semi-rigidcovering for the purpose of containing and/or directing the pressuretowards the switch. The site sensor 180 contains a reed switch or otherstyle of physical switch that is entirely encased in a non-conductivecovering which may be of any appropriate material or fabric. The sitesensor 180 uses a resonate frequency to determine the status of the sitesensor 180. The site sensor 180 uses the electronic determination of theresonate frequency and its stability and range for the purpose ofdetermining the status of the site sensor 180 and is resettable around anew frequency in the case of a partial occlusion of the site sensor 180or a slight movement of the site sensor 180 area. The site sensor 180has different chemicals or other discrete sensors applied to thediffering layers to aid in the differentiation of what may or may not becoming into contact with the site sensor 180. The site sensor 180utilizes two or more electrodes and the measurement therebetween todetermine contact with the body. The site sensor 180 utilizes a singleelectrode to determine contact with the body. The site sensor 180utilizes the separation or spacers between the various layers of thesite sensor 180 to control or calibrate the amount of blood or fluidrequired to activate an alarm condition. The site sensor 180 has a drainhole in one or more areas of the site sensor 180 to allow the occludingblood or fluid to be drained off. The site sensor 180 has one or moreholes in a top layer of non-vapor permeable membrane or a limitedpermeable membrane which would allow the aforementioned holes to becovered with a finger and pressure applied to the site sensor 180 toforce blood out of a drain hole in order to reset the site sensor 180.The site sensor 180 has a luer fitting or other appropriate fitting toallow a liquid or gas or vapor to be infused in order purge the internalspaces of the site sensor 180. The site sensor 180 has a suction port toallow the vacuum or suction removal of liquid, blood or occludingvapors. The site sensor 180 contains various chemical-determiningsensors which would allow the determination of what liquid is contactingthe site sensor 180. The site sensor 180 uses the various opticalproperties of differing liquids to determine what liquid is contactingthe site sensor 180. The site sensor 180 uses a hydrophilic inner layerwhich has a capacitive or inductive site sensor 180 to determine thepresence of liquid. The capacitive or inductive element is external tothe sensor 180 itself. The site sensor 180 uses a piezo-electric crystalor device that changes the pressure of a liquid in a hydrophilic padcontained by a rigid or semi-rigid container or package. The site sensor180 uses electro-active powders that produce an electrical potential orcurrent when wetted.

In one or more further implementations of the site sensor 180, the sitesensor 180 may include one or more of the following. The input to thesite sensor 180 is an electrical type sensor, a mechanical sensor, achemical sensor, an optical sensor, or any other type of sensor. Theinput to the site sensor 180 is a direct current (DC) voltage potential.The input to the site sensor 180 is an alternating current (AC) voltagepotential. The input to the site sensor 180 is an amplitude modulated(AM) signal. The input to the site sensor 180 is a frequency modulated(FM) signal. The input to the site sensor 180 is a pulse width modulatedsignal. The input to the site sensor 180 is a light source (of anywavelength). The input to the site sensor 180 is part of theelectromagnetic spectrum. The input to the site sensor 180 is a thermalchange. The input to the site sensor 180 is a mechanical force. Theinput to the site sensor 180 is an electrochemical change. The input tothe site sensor 180 is any combination of inputs. The sensor input issent to a computer file. The sensor input is sent to an electronicstorage or media device. The sensor input is displayed on a computermonitor. The sensor input is displayed on a medical device's userinterface. The input to the site sensor 180 is different from theoutput. The site sensor 180 operates in multiple or singular modalities.The site sensor 180 operation may change modalities.

In one or more additional implementations of the site sensor 180, thesite sensor 180 may include one or more of the following. The outputfrom the site sensor 180 is electrical, mechanical, chemical, thermal,optical, or any other type of output. The output from the site sensor180 is a direct current (VDC) voltage potential. The output from thesite sensor 180 is an alternating current (VAC) voltage potential. Theoutput from the site sensor 180 is an amplitude modulated (AM) signal.The output from the site sensor 180 is a frequency modulated (FM)signal. The output from the site sensor 180 is a pulse width modulatedsignal. The output from the site sensor 180 is a light source (of anywavelength). The output from the site sensor 180 is part of theelectromagnetic spectrum. The output from the site sensor 180 is amechanical force. The output from the site sensor 180 is anelectrochemical change. The output from the site sensor 180 is anycombination of outputs. The site sensor 180 output is different from theinput. The sensor input is different from the output. The sensor outputis sent to a computer file. The sensor output is sent to an electronicdata storage or media device. The sensor output is displayed on acomputer monitor. The sensor output is displayed on a medical device'suser interface. The sensor output is variable depending on which layersare responding or providing an output or where a variance is detectable.The sensor output is variable or progressive or regressive depending onthe amount of liquid detected by the site sensor 180.

Analytical Circuit/Enunciator:

With reference to FIG. 7, an electrical schematic of an embodiment ofthe analytical circuit 190 is shown. The analytical circuit 190illustrated is a standard comparator that compares the value of anelectrical output signal, in one embodiment, sent through the conductivewires 273 to the site sensor 180 to the value of an input signalreceived through the conductive wires 273 from the site sensor 180. Thisallows for the fail-to-safe feature of the present invention because ifa difference between the output signal and the input signal is outside adesignated range or if there is no return signal as in the case ofdetachment of the detection section 269 from the site sensor 180, theanalytical circuit 190 responds to that change by sending an outputsignal to the enunciator 200 to be actuated or causing one or moreswitches to be closed to actuate the enunciator 200. The analyticalcircuit 180 and the enunciator 200 may be powered by a power supply 302.Although the analytical circuit is show as including a comparator, inalternative embodiments, other analytical circuits may be used toprovide the fail-to-safe feature of the present invention. Further,hardware that may perform the functions described herein include, butnot by way of limitation, an application specific integrated circuit(ASIC), a set of wired logic circuits, and a hardwired circuit ofelectrical components, e.g., transistors, capacitors, and resistors.Further, hardware and software may be used to perform the functionsdescribed herein. Examples of hardware and software that may perform thefunctions described herein include, but not by way of limitation, aprogrammed computer and an application specific computer. The analyticalcircuit 190 is powered by a power supply.

In one or more implementations of the analytical circuit 190, theanalytical circuit 190 may include one or more of the following. Theanalytical circuit 190 provides electrical isolation in compliance withthe nonisolated patient connection requirements of Safe Current Limitsfor Electromedical Apparatus as required by Applicable Document 2.3. Theanalytical circuit 190 is part of the sensor 180, 310, 350. Theanalytical circuit 190 is part of the enunciator 200. The analyticalcircuit 190 is part of a sensor/enunciator assembly. The analyticalcircuit 190 may include a reset and/or mute button to reset theanalytical circuit 190 in the event of an alarm by the enunciator 200and/or mute the alarm of the enunciator 200.

In one or more implementations of the enunciator 200, the enunciator 200may include one or more of the following. The input to the enunciator200 is the output of an electrical type sensor, a mechanical sensor, achemical sensor, an optical sensor, or any other type of sensor. Theinput to the enunciator 200 is a direct current (DC) voltage potential.The input to the enunciator 200 is an alternating current (AC) voltagepotential. The input to the enunciator 200 is an amplitude modulated(AM) signal. The input to the enunciator 200 is a frequency modulated(FM) signal. The input to the enunciator 200 is a pulse width modulatedsignal. The input to the enunciator 200 is a light source (of anywavelength). The input to the enunciator 200 is part of theelectromagnetic spectrum. The input to the enunciator 200 is a thermalchange. The input to the enunciator 200 is a mechanical force. The inputto the enunciator 200 is an electrochemical change. The input to theenunciator 200 is any combination of inputs. The input to the enunciator200 is different from the output. The enunciator 200 operates inmultiple or singular modalities. The enunciator 200 operation may changemodalities. The output from the enunciator 200 is electrical,mechanical, chemical, thermal, optical, or any other type of output. Theoutput from the enunciator 200 is a direct current (VDC) voltagepotential. The output from the enunciator 200 is an alternating current(VAC) voltage potential. The output from the enunciator 200 is anamplitude modulated (AM) signal. The output from the enunciator 200 is afrequency modulated (FM) signal. The output from the enunciator 200 is apulse width modulated signal. The output from the enunciator 200 is alight source (of any wavelength). The output from the enunciator 200 ispart of the electromagnetic spectrum. The output from the enunciator 200is a mechanical force. The output from the enunciator 200 is anelectrochemical change. The output from the enunciator 200 is anycombination of outputs. The sensor output is enunciator 200 is differentfrom the input. The enunciator input is different from the output. Theenunciator output is sent to a computer file. The enunciator output issent to an electronic data storage or media device. The enunciatoroutput is displayed on a computer monitor. The enunciator output isdisplayed on a medical device's user interface. The enunciator output isvariable depending on which layers are responding or providing an outputor where a variance is detectable. The enunciator output is variable orprogressive or regressive depending on the amount of liquid or rate ofchange detected by the site sensor 180. The output of the enunciator 200goes to any electronic data storage device. The independent powersupplies for each component may differ from each other. The enunciator200 output is visual. The enunciator output is audible at any volume orfrequency. The enunciator output is vibration. The enunciator output isan electronic signal. The enunciator output is an optical/photonicsignal. The enunciator output is any part of the electromagneticspectrum. The enunciator 200 itself is of any shape or size. Theenunciator output is any combination of outputs. The site sensor 180,the analytical circuit 190 and the enunciator 200 are connected to eachother with any physical connection device.

In one or more implementations of the power supply 302 of the analyticalcircuit 190, the power supply 302 may include one or more of thefollowing. The analytical circuit 190 is powered by an external powersupply. The analytical circuit 190 is powered by an internal powersupply. The analytical circuit 190 is powered by solar energy. Theanalytical circuit 190 is powered by a combination of external andinternal or solar power supplies. The analytical circuit 190 is poweredby a combination of differing power supplies which may be internal orexternal or both. The power supply is a disposable battery. The powersupply is a rechargeable battery. The power supply's rechargeablebattery is recharged from the medical device it is attached to, such asan infusion pump or dialysis unit. The power supply is a “Cap-Battery”or other power storage device. The power supply is a proprietary orcustom battery of varying shapes or voltages or outputs. The powersupplies are independent for each component. The power supply has aredundant or a “back-up” arrangement. The power supply is monitored fora low-battery condition. The power supply is monitored for trends incapacity. The power supply is monitored for trends in capacity andindication given as to expected capacity on current cycle and/orremaining cycles before performance is considered to be unacceptable.The state of the power supply is monitored and status is displayed on auser interface such as an indicator light, graphical user interface,monitor (CRT, flat panel, etc.), or any other format as know to thoseskilled in the art. The power supply is a current storage device.

Method of Use:

With reference to FIGS. 4-7, the system will now be described in use. Anelectrical signal is sent from the analytical circuit 190 to the activesite sensor 180. This signal passes from the first sensing array 240 ofthe site sensor 180 through the resistor 276 to the second sensing array250, and back out to the analytical circuit 190. The analytical circuit190 monitors the return signal. Any change of this returned signaloutside of a designated range produces an output, which is sent to theenunciator 200 to actuate an alarm. Monitored conditions that wouldcause the returned signal to be outside of the designated range includewhen partial venous needle dislodgment occurs, and when complete venousneedle dislodgment occurs.

During partial venous needle dislodgment (not exclusively infiltrating),blood leaking around the fistula needle 150 or otherwise will flowthrough the base membrane layer 210, contacting the first sensing array240, and through the second membrane layer 220 thereby coming intocontact with the second sensing array 250. Because the sensing arrays240, 250 are resistively connected and the signal input from theanalytical circuit 190 provides a constant value through the system(allowing for a fail-to-safe feature), the change in resistance in thesensing arrays 240, 250 caused by the blood contact alters the signal sothat the returned signal to the analytical circuit 190 is outside of thedesignated range. The analytical circuit 190 responds to this conditionby energizing the enunciator 200, causing the alarm.

During complete venous needle dislodgment, the tab 268 that wraps aroundthe bloodline 160 transfers the pulling force causing the dislodgment tothe perforation 270 or otherwise weakened area, allowing the detachmentsection 169 to separate from the rest of the site sensor 180 and cuttingthe connection between the conductive wires 273 and the sensing arrays240, 250 so that the electrical circuit is opened. Severing theelectrical circuit eliminates the return signal to the analyticalcircuit 190 so that the difference between the sent signal and returnedsignal (or lack thereof) is outside of the designated range determinedby the analytical circuit 190. The analytical circuit 190 responds tothis condition by energizing the enunciator 200, causing the alarm.

Thermal Site Sensor:

With reference to FIG. 9, an alternative embodiment of a site sensor 310is shown. In this embodiment, one or more sensing arrays 320 include aplurality of thermistors 330 spaced along the sensing array 320 in aspace between a base membrane layer and a second membrane layer (andpossibly other membrane layers). The thermistors 330 are disposed withinan exothermic chemical 340 within the space between the base membranelayer and the second membrane layer (and possibly other membranelayers). The underside of the base membrane layer is adhesively coatednear its periphery and has holes that would allow the free passage ofvapor, blood, or other fluid therethrough. The exothermic chemical 340releases its thermal potential when the blood or other fluid contactsit. The resulting thermal change warms the thermistors 330, causing thethermistors 330 to change their resistive values in correlation to theamount of thermal change. This change in resistance is detected by theanalytical circuit 190 which produces an alarm. The site sensor 310includes a detachment section 269 similar to the detachment section 269described above with respect to FIG. 6.

With reference to FIG. 10, another embodiment of a site sensor 350 isshown. The site sensor 350 may include one or more sensing arrays 360comprised of one or more optical fibers 370 disposed in a space betweena base membrane layer and a second membrane layer (and possibly othermembrane layers). Similar to the embodiments shown and described above,the underside of the base membrane layer is adhesively coated near itsperiphery and has holes that would allow the free passage of vapor,blood or other fluid therethrough. The one or more optical fibers of thesensing array 360 may be connected to a light source. The exterior ofthe one or more optical fibers may be treated to encourage adhesion ofblood or other fluid thereto. Light from the light source passes throughthe one or more optical fibers between the base membrane layer and thesecond membrane layer. When blood or other fluid passes through theholes of the base membrane layer and occludes the space between the basemembrane layer and the second membrane layer and contacts the one ormore optical fibers, the light transmission through the one or moreoptical fibers is affected. This is detected by the analytical circuit,causing an alarm to be produced. In an alternative embodiment, light maypass through a block or other optical unit that would be occluded in thepresence of blood or other liquid, and the analytical circuit may detectthis. In another embodiment, a light path may be altered by the physicalpresence of blood or liquid in the space between layers, altering anoptical picture, which is detected by the analytical circuit 190 andsets off the alarm.

It will be readily apparent to those skilled in the art that stillfurther changes and modifications in the actual concepts describedherein can readily be made without departing from the spirit and scopeof the invention as defined by the following claims.

1-12. (canceled)
 13. A disposable hemodialysis site sensor attachable toat least one of a blood line and a fistula needle for alerting medicalpersonnel of the leakage of blood from an access site where the fistulaneedle enters into a patient's body and dislodgment of the fistulaneedle from the access site, the hemodialysis site sensor comprising:one or more membrane layers, at least one of the one or more membranelayers including one or more holes disposed therein to allow the passageof blood and vapor therethrough; the one or more membrane layersincluding a lower side adherable to skin of the patient; an electricalconnection adapted to be electrically coupled to an analytical circuitand including one or more resistively connected sensing arrays disposedbetween the one or more membrane layers, a disconnection mechanismattachable to at least one of the blood line and the fistula needle andsevering the electrical connection upon dislodgment of the fistulaneedle from the access site; wherein an electrical signal sent throughthe electrical connection changes when blood contacts at least one ofthe one or more sensing arrays or the electrical connection is severedby the disconnection mechanism, causing the analytical circuit toactuate an alarm notifying medical personnel of partial or totaldislodgment of the fistula needle from the access site, and thehemodialysis site sensor disposable after a single use.
 14. Thehemodialysis site sensor of claim 13, wherein the disconnectionmechanism includes an adhesive tab attachable to at least one of theblood line and the fistula needle, and a perforation along the one ormore membrane layers so that upon dislodgment of the fistula needle, thedislodgment mechanism separates from the site sensor along theperforation, causing the electrical connection to be severed.
 15. Thehemodialysis site sensor of claim 13, wherein the electrical connectioninclude a conductive wire that wraps around a patient's limb where theaccess site is.
 16. A method of alerting medical personnel of partialand total dislodgment of a fistula needle from an access site where thefistula needle enters into a patient's body during hemodialysis,comprising: providing a disposable site sensor including one or moremembrane layers, at least one of the one or more membrane layersincluding one or more holes disposed therein to allow the passage ofblood and vapor therethrough; the one or more membrane layers includinga lower side adherable to skin of the patient; an electrical connectionadapted to be electrically coupled to an analytical circuit andincluding one or more resistively connected sensing arrays disposedbetween the one or more membrane layers, a disconnection mechanismattachable to at least one of the blood line and the fistula needle andsevering the electrical connection upon dislodgment of the fistulaneedle from the access site; providing an analytical circuit inelectrical communication with the electrical connection; sending asignal from the analytical circuit to the site sensor and receiving thesignal from the site sensor with the analytical circuit, the signaltraveling through the one or more resistively connected sensing arraysof the electrical connection; partially dislodging the fistula needlefrom the access site causing blood to contact the one or moreresistively connected sensing arrays and the signal sent from theanalytical circuit to change; completely dislodging the fistula needlefrom the access site causing the disconnection mechanism to sever theelectrical connection and the signal sent from the analytical circuit tochange; determining with the analytical circuit whether the signalchanged outside of a predetermined range; actuating an alarm with theanalytical circuit if the signal changed outside of a predeterminedrange; disposing the site sensor after a single use.
 17. The method ofclaim 16, wherein the disconnection mechanism includes an adhesive tabattachable to at least one of the blood line and the fistula needle, anda perforation along the one or more membrane layers, and severing theelectrical connection with the disconnection mechanism includes severingthe electrical connection by at least one of the blood line and thefistula needle pulling on the adhesive tab and separating thedislodgment mechanism from the site sensor along the perforation,causing the electrical connection to be severed.
 18. The method of claim17, wherein the site sensor further includes a first membrane layerincluding one or more holes disposed therein to allow the passage ofblood and vapor therethrough, a first membrane layer including one ormore holes disposed therein to allow the passage of blood and vaportherethrough, and a top membrane layer, and the one or more resistivelyconnected sensing arrays include a first sensing array disposed betweenthe base membrane layer and the first membrane layer, and a secondsensing array disposed between the first membrane layer and the topmembrane layer.
 19. The method of claim 17, further including resettingthe site sensor in the event of false alarm.
 20. A method of alertingmedical personnel of a problem during hemodialysis, comprising:providing a disposable active, fail-to-safe site sensor for a fistulaneedle at an access site during hemodialysis; automatically alertingmedical personnel of a problem during hemodialysis using the active,fail-to-safe site sensor during at least the following: failing of theactive, fail-to-safe site sensor; insufficient powering to the active,fail-to-safe site sensor; partial fistula needle dislodging from theaccess site; and complete needle dislodging from the access site;disposing the site sensor after a single use.
 21. The method of claim20, wherein the disposable active, fail-to-safe site sensor includes anactive electric circuit and a disconnection mechanism attached to atleast one of a blood line and the fistula needle that opens the activeelectric circuit of the active, fail-to-safe site sensor during completeneedle dislodgment, and complete needle dislodging from the access siteincludes causing the disconnection mechanism to open the active electriccircuit of the active, fail-to-safe site sensor.
 22. The method of claim20, wherein the disposable active, fail-to-safe site sensor includes oneor more membrane layers, at least one of the one or more membrane layersincluding one or more holes disposed therein to allow the passage ofblood and vapor therethrough; the one or more membrane layers includinga lower side adherable to skin of the patient; an electrical connectionadapted to be electrically coupled to an analytical circuit andincluding one or more resistively connected sensing arrays disposedbetween the one or more membrane layers, a disconnection mechanismattachable to at least one of the blood line and the fistula needle andsevering the electrical connection upon dislodgment of the fistulaneedle from the access site; and an analytical circuit in electricalcommunication with the one or more resistively connected sensing arraysof the electrical connection and sending an electrical signaltherethrough, and automatically alerting medical personnel of a problemduring hemodialysis using the active, fail-to-safe site sensor when thedifference between the electrical signal sent by the analytical circuitand the electrical signal received by the analytical circuit is beyond apredetermined range.
 23. The method of claim 22, wherein the active,fail-to-safe site sensor further includes a first membrane layerincluding one or more holes disposed therein to allow the passage ofblood and vapor therethrough, a first membrane layer including one ormore holes disposed therein to allow the passage of blood and vaportherethrough, and a top membrane layer, and the one or more resistivelyconnected sensing arrays include a first sensing array disposed betweenthe base membrane layer and the first membrane layer, and a secondsensing array disposed between the first membrane layer and the topmembrane layer.
 24. The method of claim 20, further including resettingthe site sensor in the event of false alarm.